A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

Last updated: May 24, 2024
Sponsor: CARsgen Therapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Pancreatitis

Pancreatic Disorders

Treatment

CT041 autologous CAR T-cell injection

Clinical Study ID

NCT05911217
CT041-ST-05
  • Ages 18-79
  • All Genders

Study Summary

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation in the clinical trial; fully understand, be informed aboutthis study and have signed the ICF; willing to follow and able to complete all studyprocedures;

  2. Aged 18 to 79 years;

  3. Histologically confirmed pancreatic ductal adenocarcinoma;

  4. Macroscopic complete tumor removal (R0 or R1 resection);

  5. Postoperative pathological stage (pTNM): T1-3, N0-2, M0;

  6. Immunohistochemistry (IHC) staining of subject's tumor tissue sample isCLDN18.2-positive;

  7. Subjects had recovered from surgery and had received 3 months of standard adjuvanttherapy;

  8. Abnormal CA19-9 level;

  9. With sufficient venous access for leukapheresis collection;

  10. ECOG performance status score 0-1;

  11. Adequate organ function;

  12. Men and women of childbearing potential must be willing to use effective methods ofcontraception to prevent pregnancy;

Exclusion

Exclusion Criteria:

  1. Prior neoadjuvant therapy for pancreatic cancer;

  2. Subjects with borderline resectable pancreatic cancer;

  3. Present or past history of metastatic or locally recurrent pancreatic cancer;

  4. Evidence of malignant ascites;

  5. Subjects had diseases that may interfere with CA19-9 level, including but notlimited to cholangitis, pancreatitis, obstructive jaundice, etc.

  6. Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2,except alopecia and other tolerable events as judged by the investigator orlaboratory abnormalities allowed in this study;

  7. Pregnant or lactating women;

  8. Positive serology for HIV, Treponema pallidum or HCV;

  9. Any active infections, including but not limited to active tuberculosis, HBV, EBV,CMV, COVID-19 infections;

  10. Clinically significant thyroid dysfunction;

  11. Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredientsand other serious allergic history;

  12. Subjects who may be at high risk for potential digestive tract bleeding orperforation;

  13. Known active autoimmune disease, including but not limited to, psoriasis orrheumatoid arthritis, or other conditions requiring long-term immunosuppressivetherapy;

  14. Subjects who have a history of organ transplantation or are awaiting organtransplantation;

  15. Subjects who require anticoagulant therapy;

  16. Subjects who are receiving or are expected to require long-term antiplatelet therapyduring the study;

  17. Subjects who have experienced major surgery or have significant trauma within 4weeks before apheresis, or who are expected to undergo major surgery during thestudy period;

  18. Previously received any gene-modified cell therapies (including CAR T, TCR T);

  19. Subjects who have other serious diseases that may restrict them from participatingin the study assessed by investigators;

  20. Subjects with oxygen saturation ≤ 95%;

  21. Subjects who have signs of central nervous system diseases or clinically significantneurological examination abnormalities;

  22. Subjects who have other uncured malignant tumors in the past 3 years or at the sametime, except those with very low degree of malignancy such as cervical cancer insitu and basal cell carcinoma of skin;

  23. Vaccination with live attenuated vaccines within 4 weeks prior to apheresis orplanned during the study;

  24. Subjects who are unable to or unwilling to comply with the requirements of the studyprotocol as assessed by investigators.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: CT041 autologous CAR T-cell injection
Phase: 1
Study Start date:
July 11, 2023
Estimated Completion Date:
December 31, 2026

Study Description

This study is an open, multicenter, Phase Ib clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive pancreatic cancer who has undergone adjuvant chemotherapy. The aim of this study is to evaluate the efficacy, safety of CT041 treatment.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai 201321
    China

    Active - Recruiting

  • Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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